The NEJM study of 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events received either saxagliptin or placebo and were examined for a median of 2.1 years. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Saxagliptin did not increase or decrease the rate of ischemic events, but more patients in the saxagliptin group were hospitalized for heart failure compared to the placebo group (3.5% vs. 2.8%; hazard ratio 1.27; 95% CI 1.07–1.51; P=0.007).

The FDA considers the data from the NEJM study to be preliminary, and will be using this clinical trial data as part of its broader evaluation of type 2 diabetes drugs in terms of cardiovascular risk. Patients are warned to not stop taking saxagliptin and to speak with their health care professionals with any questions or concerns. Health care professionals are advised to continue to adhere to the prescribing recommendations in the drug labels.